Hand-held infrared scanner for early detection of melanoma Project Summary/Abstract: Melanoma incidence is increasing at one of the fastest rates for all cancers in the United States, with a current lifetime risk of 1 in 58 [1]. Approximately 68,720 melanomas will be diagnosed in 2010, with nearly 8,650 resulting in death [2]. At present, there are no systemic agents available that significantly extend the lifespan of patients with advanced disease and the key to improved survival in all affected individuals remains early diagnosis and treatment. The vast majority of cutaneous melanomas present as pigmented lesions of the skin, and current detection of atypical lesions rely on the subjective ABCDE criteria. The existence of an accurate, simple, objective and quantitative, non-invasive screening and diagnostic tool would therefore be invaluable for the early detection of malignant melanoma in a variety of clinical settings. We hypothesize that malignant pigmented lesions with increased proliferative potential generate quantifiable amounts of heat and possess an ability to reheat more quickly than the surrounding normal skin, thereby creating a marker for melanoma detection. Prior research of the PI, involving a patient study, suggests that the high-accuracy and resolution visualization of the transient thermal response of the skin to a cooling excitation allows for the identification of melanoma lesions in an early stage of the disease and holds the promise of quantifying the malignant potential of skin lesions using a simple numerical scale (from 1 to 10). In the proposed study we plan to: 1. Design, build, calibrate and test in a patient study a prototype hand-held, high-resolution infrared scanner for distinguishing pigmented lesions of varying malignant potential 2. Conduct a patient study to establish quantitative scale describing the malignant potential of a pigmented lesion based on measurement of the transient thermal response 3. Develop and optimize the software and hardware for the imaging and quantitative assessment of pigmented lesions of varying malignant potential The long-term goals of this study are to design, build and optimize a noninvasive, in vivo infrared imaging tool for the quantitative assessment of cutaneous pigmented lesions in order initiate large-scale clinical trials to evaluate and compare the sensitivity and specificity of the proposed tool with other in vivo diagnostic and imaging techniques. Such a tool is expected to decrease unnecessary skin biopsies of benign pigmented lesions and the morbidity and mortality associated with melanoma diagnosis and therapy. An interdisciplinary team will be involved in the research effort: two engineers will be responsible for the development of software and hardware and the modeling effort, three clinicians with expertise in dermatology will be leading the patient recruitment effort for the patient study, and one expert from the public health area will be leading the clinical trial design, conduct, and data analysis efforts. Intellectual property generated through these studies is expected to lead to a biotechnology startup company focused on infrared imaging of cutaneous lesions. PUBLIC HEALTH RELEVANCE: This new, collaborative R01 grant proposal seeks to develop a novel infrared imaging tool, a high-resolution, high-accuracy, hand-held scanner, to aid in the clinical detection and quantitative assessment of atypical pigmented lesions, and melanoma in particular. Translational goals include the design and manufacturing of a prototype device, the evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions to identify high-risk lesions and melanomas and optimization of this scanning technology and the computational model supporting the diagnostic feature.